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North San Antonio News

Tuesday, December 24, 2024

How many companies in cities across Kendall County received FDA citations in 2023?

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

There was one company in a city associated with Kendall County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous year.

The citations in the county include:

  • The facility design was observed to allow the influx of lesser quality air into a classified area containing higher quality air.
  • Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
  • Personnel performed aseptic manipulations with exposed hair or skin.

The company cited had to take regulatory and/or administrative actions.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Companies Located Within Kendall County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Strive Pharmacy Texas, LLCDrugs09/08/2023Facility design, influx of lesser quality air
Strive Pharmacy Texas, LLCDrugs09/08/2023Failure to clean and disinfect/sterilize equipment, ISO 5 area
Strive Pharmacy Texas, LLCDrugs09/08/2023Personnel exposure during aseptic manipulations

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